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FDA 510(k)

NEO DENTA ZIRCONIA

K-Number: K130198 · 2013-10-21

ApplicantNeo Group Limited
Decision Date2013-10-21
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NEO DENTA ZIRCONIA is the device name listed in this FDA 510(k) record. The listed applicant is Neo Group Limited. It received FDA 510(k) clearance on 2013-10-21 under 510(k) number K130198. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEO DENTA ZIRCONIA?

NEO DENTA ZIRCONIA is a medical device that received FDA 510(k) clearance on 2013-10-21. The listed applicant is Neo Group Limited. The 510(k) number is K130198.

When did NEO DENTA ZIRCONIA receive FDA 510(k) clearance?

NEO DENTA ZIRCONIA received FDA 510(k) clearance on 2013-10-21, under 510(k) number K130198.

Who is the listed applicant for NEO DENTA ZIRCONIA?

The FDA 510(k) record lists Neo Group Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEO DENTA ZIRCONIA?

The FDA product code for NEO DENTA ZIRCONIA is EIH.

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Related Devices (Code: EIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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